Expanding Access to Home-Based Palliative Care
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|ClinicalTrials.gov Identifier: NCT03128060|
Recruitment Status : Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Congestive Heart Failure Chronic Obstructive Pulmonary Disease||Other: Home-based palliative care Other: Enhanced usual care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Expanding Access to Home-Based Palliative Care Through Primary Care Medical Groups|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: Home-based Palliative Care
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Other: Home-based palliative care
The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
Other Name: Home-based primary palliative care
Active Comparator: Enhanced Usual Care
Enhanced usual care refers to usual primary care provided by a primary care physician who has received special training in the core elements of palliative care.
Other: Enhanced usual care
Usual primary care consists of appointment-based access to primary care providers (PCPs) as requested by the patient. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.
- Change in Score on Condensed Memorial Symptom Assessment [ Time Frame: At baseline and 1- and 2- months following baseline ]This is a brief and reliable (Cronbach alpha: 0.85) self-report assessment that measures the frequency and intensity of a variety of physical and psychological symptoms.
- Change in Score on Hospital Anxiety and Depression Scale [ Time Frame: At baseline and 1- and 2- months following baseline ]The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D).
- Change in Score on PHQ-9 [ Time Frame: At baseline and 1- and 2- months following baseline ]This is a 9-item assessment to diagnose depression. It is based on the nine DSM-IV criteria for depression
- Change in Score on Pain Numerical Rating Scale [ Time Frame: At baseline and 1- and 2- months following baseline ]This is an 11-point (0 to 10) pain assessment that is valid (α=.83) and reliable (α=.85) in assessing pain change.
- Change in Score on Hearth Hope Index [ Time Frame: At baseline and 1- and 2- months following baseline ]This 12-item scale is used to assess hope as it relates to a person's ability to cope with medical illness, loss, and related psychosocial stressors.
- Change in Consultation Care Measure [ Time Frame: At baseline and 1- and 2- months following baseline ]This patient-reported assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128060
|Contact: Susan Enguidanos, Ph.D.||(213) firstname.lastname@example.org|
|Contact: Anna Rahman, Ph.D.||email@example.com|
|Principal Investigator:||Susan Enguidanos, Ph.D.||USC Davis School of Gerontology|